David H. Newman, MD
Director of Clinical Research
St. Luke’s/
212-523-3981
E-mail dnewman@chpnet.org
Office Hours will be arranged on an individual
basis, please email or call.
Course
Description: This course is designed to
introduce students who are interested in medical careers to the goals,
nomenclature, principles, and practical reality of clinical research, with an
emphasis on the emergency department (ED) setting. The course focuses on terminology,
data collection techniques, research design, and basic biostatistics.
Understanding research and clinical emergency medicine as an avenue to
understanding clinical studies and their implications will be emphasized. Group
exercises will include design and implementation of two factitious hypothetical
studies where funding, time scale, and resource availability will be
considered. A mid-term examination will concentrate on terminology, data
collection techniques, and a final examination will focus on research design.
Basic didactic biostatistics material will be taught primarily for purposes of
familiarization and interpretation of research and will be aimed at the
non-mathematician (no Math or Statistics pre-requisites). There will be an
option for a 1-point or 2-point version of the course when registering.
The 1-point course will include didactic material and one lecture per
week, and will not include ED time. The 2-point course (limited to 40
students per semester) in which students will act as research
assistants will require inclusion in the Academic Associates research
assistant program at St. Luke's/Roosevelt Hospital ED. This includes two 4-hour
shifts per week of ED time in which students will learn how to assist in the
execution of clinical research including performing consents, data collection,
and database interaction (for further details regarding the Academic Associate
program, see the web site (http://www.columbia.edu/cu/aap/).
ED time will be arranged to fit in and around the student's academic schedule
as needed. Additionally, three to five evening practical sessions will cover
ongoing individual ED projects in depth, and students will be shown and instructed
on basic procedural skills in emergency medicine (lumbar puncture, endotracheal intubation, etc.) as well as shown dynamic and
static invasive imaging including ultrasound, CT scans, and others.
The 2-point course is
recommended for those students looking to gain clinical research experience and
hands on ED time with physicians in the clinical setting.
Lecture
Time: T 5:40-7:20
Room:
TBA
Website: Courseworks will be
utilized for posting of electronic materials.
Text:
TBA. Most relevant reading materials will be handed out. | A user-friendly medical
dictionary will be helpful
Reserve
Lectures: See lecture schedule below. Sporadic evening sessions
during the semester, in addition to lectures, will address specific research
projects and their related anatomy, physiology, and research methodology, as
well as practical and clinical skills. Sessions will be given by Dr. Newman and
other emergency medicine and research faculty.
Clinical: Two shifts total per week
as a research assistant in the St. Luke’s or Roosevelt Hospital Emergency
Department are required. Shift attendance is mandatory. Orientation for shifts
will occur early, occasionally during the first week of class; pre-registration
is highly recommended.
Exams:
Mid-term covering the first half of the course and a final exam emphasizing the
final half.
Grading:
Mid-term - 35%
Final - 35%
Participation - 30%
|
Date |
Lecture |
Discussion
|
|
|
Lecture
1 |
Intro/Overview |
Purpose/goals
of clinical research |
|
|
Lecture
2 |
Basic
study nomenclature |
Terminology
and precision |
Handout |
|
Lecture
3 |
Data
collection techniques |
Research
assistant role in the clinical setting |
Handout |
|
Lecture
4 |
Biostats
1 |
Review/discussion |
Handout |
|
Lecture
5 |
Institutional
Review Board/ Biostats 2 |
Federal
regulation and subject protection |
Handout |
|
Lecture
6 |
Mid-term |
-- |
-- |
|
Lecture
7 |
Research
Design |
Case
reports, surveys, cohort studies |
Handout |
|
Lecture
8 |
Research
Design |
Case-control
studies, Randomized controlled trials |
Handout |
|
Lecture
9 |
Research
Design |
Group
exercise - design of 2 factitious studies |
Handout |
|
Lecture
10 |
|
Understanding
research (lay vs scientific press) |
Handout |
|
Lecture
11 |
Peer
Review |
Intro
to scientific journals, peer review |
Handout |
|
Lecture
12 |
Final
Examination |
-- |
-- |